Regenerative medicine product regulations in Japan - Enhancing the development of Advanced Therapies?

Case study

Colin Lee Novik -
Managing Director,
CJ Partners Inc., Japan

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16:30
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17:00

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Recent regulatory innovation in cell therapy in Taiwan

In today's presentation, I will introduce the regulatory history of cell therapy medicinal products in Taiwan, then I will provide the audience with statistics regarding the current status of cell therapy clinical trials. Also, I will talk about the recent regulatory innovative measures in order to reduce the regulatory burden and facilitate the approval process of clinical trials and market authorizations.

I-Ning Tang -
Team Leader,
Center for Drug Evaluation (CDE)

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17:00
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17:30

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Discussion Panel: Working towards a cooperative framework for regulatory harmonisation across Asia

In today's presentation, I will introduce the regulatory history of cell therapy medicinal products in Taiwan, then I will provide the audience with statistics regarding the current status of cell therapy clinical trials. Also, I will talk about the recent regulatory innovative measures in order to reduce the regulatory burden and facilitate the approval process of clinical trials and market authorizations.